[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Page 12832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04248]
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DEPARTMENT OF VETERANS AFFAIRS
Request for Information: Public-Private Collaborations in Pain
Research
AGENCY: Office of Research and Development, VA.
ACTION: Notice.
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SUMMARY: The Department of Veterans Affairs (VA) publishes this Request
for Information (RFI) on public-private collaborations in pain
research, seeking to connect the Veterans Health Administration's (VHA)
Office of Research and Development (ORD) with commercial organizations
that are conducting, or have an interest in conducting, pain research
through a Cooperative Research and Development Agreement (CRADA). The
CRADA is to develop public-private collaborations in pain research with
the intent of developing novel therapies that will benefit Veterans
suffering from chronic pain conditions.
DATES: This notice will remain open indefinitely to accept inquiries
and responses.
FOR FURTHER INFORMATION CONTACT: Interested parties should contact
Audrey Kusiak, Ph.D., Scientific Program Manager, at (202) 443-5770 or
by email at [email protected]. Please use the subject line: ``VHA CO
ORD PAIN PUBLIC PRIVATE COLLABORATIONS.'' You may also write to
Veterans Health Administration, Office of Research and Development
(10P9R), 810 Vermont Avenue NW., Washington, DC 20420. When responding,
please provide the name of your organization, the main area of research
interest, your name and title, and contact information (including
mailing address, email address, and phone number). Do not include
proprietary, classified, confidential, or sensitive information in your
response.
SUPPLEMENTARY INFORMATION: VA is seeking to identify commercial
organizations that are interested in the development and translation of
novel therapies for chronic pain. Collaboration will be made via a
CRADA under the authority of the Federal Technology Transfer Act of
1986 (FTTA), Public Law 99-502, October 20, 1986, codified at 15 U.S.C.
3710a. Under the FTTA, VA and the private party may exchange personnel,
services, facilities, equipment, intellectual property, or other
resources. No Federal funds may be provided to the collaborator, but
the VA laboratory is authorized to accept Federal funds. VA may grant
to the collaborating party a license or an assignment to inventions
made under the CRADA. VA will select collaborators based on a mutually
beneficial relationship that is fair and equitable, with the goal of
alleviating pain in the Veteran population.
Under the CRADA, VA's duties will include connecting industry
collaborators with appropriate VA investigators conducting pain
research. Further, VA will provide expertise in the development and
implementation of pre-clinical testing (e.g., good laboratory practice)
of viable therapies to investigational new drugs; design and
implementation of clinical trials; and development of a data-sharing
plan.
This RFI invites feedback from private entities that are interested
in conducting public-private collaborations with VA that is focused on
translational research of chronic pain. Area(s) of interest to VA
include, but are not limited to, the following:
(a) Building on the clinical usefulness of animal models and
outcome measures;
(b) Capitalizing on the heterogeneity and complexity of the VA pain
population;
(c) Developing relevant therapeutic strategies for the treatment of
polytrauma associated pain, including phantom limb, neuropathic pain,
headaches, complex regional pain syndrome, burns, chronic back pain,
arthritic (joint) pain, etc.;
(d) Conditions co-existing with chronic pain such as Post-traumatic
Stress Disorder, fibromyalgia, irritable bowel syndrome, and chronic
fatigue syndrome, and how these conditions contribute to pain
perception;
(e) Understanding the mechanisms in the development of acute to
chronic pain and how to modulate them; and
(f) Safety and the abusive nature of opioid medication.
VA will evaluate submissions, and selected candidates will be
requested to enter into a CRADA with VA. Special consideration will be
given to small business firms and consortia involving small business
firms. Preference will also be given to businesses located in the
United States, which agree that those products embodying inventions
made under the CRADA will be manufactured substantially in the United
States as provided for in 15 U.S.C. 3710a(c)(4).
This RFI does not obligate VA to enter into a CRADA with any
respondents. VA reserves the right to establish a CRADA based on
scientific analysis and capabilities found by way of this announcement
or other searches, if determined to be in the best interest of the
government.
Approved: February 14, 2013.
John R. Gingrich,
Chief of Staff, Department of Veterans Affairs.
[FR Doc. 2013-04248 Filed 2-22-13; 8:45 am]
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